Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple pregnancies are considered a risk factor for all those adverse outcomes. The main objective of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an improvement of birthweight compared to placebo in twin pregnancies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Gestational age between 8 0/7 and 13 6/7 weeks

• Twin pregnancy confirmed by ultrasound

Exclusion Criteria:

• One or two negative heart beat

• Previous hypertensive disorder of pregnancy

• Pre-existing hypertension or diastolic blood pressure >90 mmHg at randomization

• Pre-existing nephropathy

• Pre-existing diabetes (type 1 or 2)

• Anaphylactic allergy to lactose

• Known coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)

• Use of heparin or other anticoagulants.

• Contre-indications to aspirin

• Discordance of crown-rump length greater than 20%.

• Fetal anomalies (cystic hygroma, nuchal translucency > 95th percentile, anencephaly, omphalocele, etc.)

• Previous or current gastric ulcer